Cleared Traditional

K231395 - INNO SLA Submerged Narrow Implant System

K231395 is an FDA 510(k) clearance for INNO SLA Submerged Narrow Implant System, manufactured by Cowellmedi Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K231395 · Cowellmedi Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
156d
Days
Class 2
Risk

K231395 is an FDA 510(k) clearance for the INNO SLA Submerged Narrow Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Cowellmedi Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on October 18, 2023 after a review of 156 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Cowellmedi Co., Ltd. devices

FDA 510(k) Submission Details - K231395

510(k) Number K231395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2023
Decision Date October 18, 2023
Days to Decision 156 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 127d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 758
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K231395.
Single Platform SP1 Implant System
K232418 · Southern Implants (Pty), Ltd. · Dec 2023
Neodent Implant System - GM Zygomatic Implant System
K232099 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · Oct 2023
UNIdental Symphony Implant System
K221315 · Unidental Co., Ltd. · Oct 2023
Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL
K230104 · Anthogyr · Oct 2023
MRI compatibility for existing BioHorizons dental implants and abutments
K223697 · BioHorizons Implant Systems, Inc. · Oct 2023
MegaGen Dental Implant Systems Portfolio - MR Conditional
K230618 · Megagen Implant Co., Ltd. · Oct 2023